Technical field
The present invention relates to a novel pharmaceutical composition comprising N-acetyl cysteine as active component.
N-Acetyl cysteine is used to dissolve or at least reduce the viscosity of mucous as produced in the breath ways, and including not only the lung tree but all the upper air ways including the cavities in the forehead and the cheeks, to prevent or treat sinuitis, to thereby eliminate or reduce the sympthoms of virus infections causing rinitis, bronchitis and other respiratory tract congestion. Acetyl cysteine will also be used as a scavenger to prevent cell death due to free radicals, and to prevent nitrate intolerance following chronic treatment with nitroglycerine and sustained release nitrate formulations.
N-Acetyl cysteine has hitherto been administered in the form of an effervescent composition which is dissolved in water by a carbon dioxide generating system prior to administration, or in the form of granules which are dissolved in water prior to use, or in the form of a matrix tablet comprising a skeleton of an insoluble polymer, which tablet leaks out N-acetyl cysteine into both the gastric and intestinal juices.
N-Acetyl cysteine has few reported side effects except an irritating effect on the mucous membrane in the stomach. It also has an extremely bad taste which per se creates a great problem in administering it.
The problem of the effervescent tablet composition containing N-acetyl cysteine, which presently is on the market, is that it has a very rapid onset of N-acetyl cysteine release. Thus, the effervescent composition, as well as the granulate present on the market, achieves a maximum blood plasma level within 1 hr from administration. The matrix formulation shows such a maximum point at 2-2.5 hrs after administration.
The object of the present invention is to obtain a pharmaceutical composition comprising N-acetyl cysteine and which composition has an improved bioavailability of N-acetyl cysteine.